Psychiatric medications, science, marketing, psychiatry in general, and occasionally clinical psychology. Questioning the role of key opinion leaders and the use of "science" to promote commercial ends rather than the needs of people with mental health concerns.

Saturday, December 09, 2006

You may have thought I had nothing more to say about the ARISE-RD study, in which risperidone (Risperdal) was used as an adjunctive (add-on) treatment for depression, but, incredibly, there is more information pertinent to its discussion.If you are already familiar with the issues surrounding the authorship of the paper, please skip ahead two paragraphs.

You may recall the authorship being altered from when this study was presented in abstract form (presented at the AmericanCollege of Neuropsychopharmacology conference) to when it was published in final form in Neuropsychopharmacology.I took exception to Keller (a big name in psychiatry) being added to the paper as an author, as he did not appear on the previous abstract as an author.I hypothesized that Keller was added because his big name gives the study an air of scientific credibility.Especially given the study’s unimpressive results (and clear use of statistical legerdemain), adding a big name was an excellent marketing ploy by Janssen.

To quote from my earlier piece on the authorship of this paper: “What did he [Keller] do to get on the study? Keller is credited with “study concept and design,” which I would deem impossible since, if he really conceived and designed the study, he would have appeared as an author on the earlier abstract. Yet he is listed fourth on the list of people who designed the study. He is also credited, along with all of the authors, with “analysis and interpretation of the data” and critical revision of the manuscript for “important intellectual content.” Is it possible that he did a great job of helping to revise the manuscript? I suppose, but it seems there were plenty of other people who were also involved with the writing of the paper. Note that Keller was not credited with “drafting of the manuscript.” So Keller did not recruit participants, provided no administrative support, did not provide statistical expertise, and did not draft the manuscript, but apparently helped design the study after it was completed! Very impressive indeed.

So now, to the point of this post.I tracked down that this study was presented previously on two or three other occasions outside of at the ACNP conference.It was presented at the 2003 American Psychiatric Association conference (possibly in two different forms, though I am not sure on this point) as well as at the 2004 American Psychiatric Association conference and the NCDEU 2003 conference. See here on page 138 for the NCDEU reference and here for the 2003 and 2004 American Psychiatric Association references.

Both Keller and Nemeroff are conspicuously absent from the 2003 and 2004 APA and NCDEU presentations, yet both appear on the final manuscript as authors. Nemeroff appears as the lead author on the 2004 ACNP abstract for the study despite not appearing at all on prior presentations. Keller, who allegedly helped design the study, only appears on the final manuscript -- he appears on not a single presentation of the study data.To top it off, a press release touted Keller and Nemeroff as co-principal investigators on the study.Obviously, if they were really principal investigators, in any meaningful sense of the term, their names would have appeared on all earlier presentations of the data. Before doing this additional research, it seemed Keller’s contributions were minimal at best, and now it appears that Nemeroff’s work can now also be called into question, as he appears nowhere on earlier presentations prior to the ACNP presentation.

At this point, I would say the evidence is quite clear that the changing authorship of the paper had little to do with which authors were responsible for conducting the study, running analyses, and writing the paper. But it sure makes for excellent marketing when big names like Nemeroff and Keller stick their names in the authorship line.Please feel free to read the entire story, starting with a more detailed description of the authorship saga, followed by the covered-up conflicts of interest, and, finally, the tricky use of statistics.

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About Me

I'm an academic with a respectable amount of clinical experience and no drug industry funding. Given my lack of time, don't expect multiple daily updates. Certain things about clinical psychology, the drug industry, psychiatry, and academics drive me nuts, and you'll probably pick up on these pet peeves before long...